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BD Introsyte Autoguard

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD Introsyte Autoguard FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
INTROSYTE AUTOGUARD 18G INTRO ONLY FDA UDI
Model / Reference
384011 FDA UDI
Description
INTROSYTE AUTOGUARD 18G INTRO ONLY FDA UDI

Identifiers

Catalog Number
384011 FDA UDI
Primary DI / UDI-DI
00382903840113 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Vascular catheter introduction set, nonimplantable

BD Introsyte Autoguard by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Becton Dickinson And Company

Sources (1)

  • FDA UDI 1b4951ee-27b6-4172-b571-bab8e9a649a3 34 fields · synced Jun 8, 2026